H4 - manufacture date added; d9 - device return date added.The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the returned device confirms the event that the metal cylindric pin could be removed easily without resistance.The pin is not designed to be detachable; without the pin the adjusting device is not locked to the distal targeting arm, so a secure drilling and screw placement was not possible.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that: ¿before the surgical procedure, ensure that all components prepared for the procedure function correctly with each other.¿ based on investigation, the root cause was attributed to a device-design related issue.The inspection confirmed the reported event: the metal cylindrical pin could be removed easily without resistance.The pin is not designed to be detachable; without the pin the adjusting device is not locked to the distal targeting arm, so a secure drilling and screw placement is not possible.The issue was already addressed by a non-conformity report; the nc investigation showed that the pin can fall of the guide block due to discrepancies in the design (transition fit instead of press fit).Nc is closed and capa is in finalize implementation phase.If any further information is provided, the complaint report will be updated.
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